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1+3 restrictions bill for generics & IMDs was passed

By Lee, Jeong-Hwan | translator Choi HeeYoung

21.04.28 16:13:13

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Up to three biological equivalence tests and clinical items may be directly shared

The first bill subcommittee of the Welfare Committee voted to revise the bill of Seo Young-seok and Seo Jung-sook


The number of joint biological equivalence tests and joint clinical trials of generic and data IMDs is expected to be limited to three consignment companies per manufacturer. Only three additional medicines can be licensed for biological equivalence tests or clinical trials.

However, biological drugs such as high-tech new drugs and vaccines and medicines designated by the head of the MFDS may be exempted from regulations on "Common Biological Equivalence Testing and Clinical 1+3 Restriction."

On the 28th, the National Assembly's Health and Welfare Committee passed the 1+3 restrictions bill on drug co-development. The first bill subcommittee of the Welfare Committee voted to revise the bil

Lee, Jeong-Hwan(junghwanss@dailypharm.com)
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